NCT02111460

Brief Summary

This is a randomized parallel control trial to evaluate whether radical loco-regional Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

5.8 years

First QC Date

April 9, 2014

Last Update Submit

May 6, 2020

Conditions

Nasopharyngeal Carcinoma

Keywords

InitiallyUntreatedDistant metastatic

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.

    2 years

Secondary Outcomes (2)

  • Progress-free survival

    2 years

  • Complete Response (CR)

    after the completion of the chemoradiotherapy treatment (up to 9 weeks)

Study Arms (2)

Radiotherapy

EXPERIMENTAL

Systemic Chemotherapy Combined with Loco-regional Radiotherapy

Radiation: Loco-regional Radiotherapy

Chemotherapy

ACTIVE COMPARATOR

Chemotherapy alone without Loco-regional Radiotherapy

Radiation: Loco-regional Radiotherapy

Interventions

Loco-regional RadiotherapyRADIATION

with or without Loco-regional Radiotherapy

ChemotherapyRadiotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients with initial untreated metastatic nasopharyngeal carcinoma
  • Histologic diagnosis of nasopharyngeal carcinoma
  • T1-4N0-3M1,IVC(according to the 7th AJCC edition)
  • Aged between 18 and 65 years
  • KPS≥70
  • The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu
  • Voluntary to participate and sign informed consent document

You may not qualify if:

  • The patients suffered from serious neurologic disease
  • Clinically significant cardiac, heart function less than or equal to 3 level
  • Clinically significant respiratory disease,lung function less than or equal to 3 level
  • Blood routine examination: WBC\<3×109/L, Hemoglobin\<90g/L, platelet count\<75×109/L
  • Abnormal liver function: total bilirubin or ALT or AST\>2×ULN
  • Abnormal renal function:serum creatinine\>1.5×ULN
  • Pregnant or lactating women
  • The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

  • You R, Liu YP, Huang PY, Zou X, Sun R, He YX, Wu YS, Shen GP, Zhang HD, Duan CY, Tan SH, Cao JY, Li JB, Xie YL, Zhang YN, Wang ZQ, Yang Q, Lin M, Jiang R, Zhang MX, Hua YJ, Tang LQ, Zhuang AH, Chen QY, Guo L, Mo HY, Chen Y, Mai HQ, Ling L, Liu Q, Chua MLK, Chen MY. Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1345-1352. doi: 10.1001/jamaoncol.2020.1808.

    PMID: 32701129DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ming y Chen, MD,Phd

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor & chief physician

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 11, 2014

Study Start

October 1, 2013

Primary Completion

August 1, 2019

Study Completion

December 1, 2022

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations

CN(1)